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Accreditation, certification, certificates…the structure that supports the third-party audit system can be very confusing! Further, an audit company offers a menu of audits: An audit to their own private standard, audits to several GFSI benchmarked schemes, and perhaps in the future, an “FDA accredited” audit. How do you know which one you need? How do you know which best prepares you for FSMA?

Jennifer McEntire spoke during the session, “Staying Ahead of New USDA and FDA Mandates for Controlling Pathogens in Food Processing” at the Food Safety Consortium conference. LEARN MOREUntil the compliance dates for the Preventive Controls rules pass, food manufacturers really only need to be compliant with good manufacturing practices (GMPs), from a regulatory standpoint. There are some specific audits that evaluate adherence to GMPs, but many companies wanted to take their food safety programs to the next level by demonstrating that they were implementing effective food safety management systems. Certification to a GFSI-benchmarked audit scheme (BRC, SQF, FSSC22000, IFS, etc.) was a primary means to show a commitment to food safety and the demonstration of exemplary programs. With the finalization of the Preventive Controls Rules, FDA is catching up. So how do the FDA requirements compare with the main elements of the GFSI Guidance Document?

Let’s evaluate the extent to which the scope of GFSI aligns with FSMA. In September, the Preventive Controls for Human Food rule was finalized, and the areas addressed within that rule constitute the bulk (although not all) of the topics covered by GFSI (GFSI covers additional areas for which FDA has not yet finalized rules, such as food defense and traceability). The question on everyone’s mind is, “If I’m certified to a GFSI-benchmarked audit scheme, am I compliant with the rule?” The answer is, “You’re probably in way better shape than someone who is not certified.” The reason is, regardless of which GFSI benchmarked audit scheme you choose, your facility will need to demonstrate, through fairly exhaustive documentation, the nature and validity of the programs that are in place, and the proof that those programs are followed day in and day out. FDA is looking for the same thing.

The Preventive Controls rules go beyond strict HACCP in that they require facilities to consider what has historically been termed the HACCP system. This includes programs that may not be critical control points (CCP) per se, but are critical to the safety of the food product. FDA identifies elements of sanitation and allergen control, as well as a supplier program, in this category. If you’re familiar with FSSC 22000, you might call these “operational prerequisite programs”. FDA will want to see how each and every hazard is evaluated to determine if it needs a preventive control, whether that is a traditional CCP or another control. For the most part, this is aligned with the GFSI benchmarked schemes, although some of the language may differ.

When it comes to the implementation of a supplier program, facilities should be aware that FDA’s requirements of such a program are much more explicit than most of the GFSI-benchmarked schemes. Even if the result is the same at the end of the day, FDA inspectors may be looking for companies to follow a fairly structured approach compared to a GFSI auditor.

To further complicate matters, FDA will be finalizing a program for the accreditation of third-party auditors. If an effective private third-party audit system exists, why is FDA adding another layer with its own form of audits (separate from inspections)? The answer lies with Congress, not FDA, as it identified two specific circumstances in which a special regulatory audit would be necessary. One situation is when a facility (or their customer) wishes to participate in the forthcoming Voluntary Qualified Importer Program. The second is if FDA has determined that the food poses food safety risks such that a facility wishing to export that food needs a certification issued by an auditor under this program. In neither case will domestic facilities be audited under this program; this program only applies to foreign facilities and only in very limited instances.

Since the rule and accompanying guidance documents related to accreditation of third-party auditors hasn’t been issued by FDA, it is premature to comment on how these audits will compare to those in use by private industry today.

So with the implementation of new rules from FDA, is there still a market for audits? Absolutely. From a very practical standpoint, FDA won’t be inspecting most facilities on an annual basis, and many private audits are conducted on an annual schedule. Plus, industry typically pushes itself further than regulations, which lag behind. Regulations can be viewed as the floor for expectations, but not the ceiling. Moving forward, we expect audit standards and private audits to become even more stringent and aggressive in terms of promoting the very best food safety practices. But beware, as history has shown us, a certificate is not a guarantee or indication of the ongoing quality of a plant’s food safety system. This is why FDA will not blindly accept that a facility has a favorable audit; regardless of the audit certifications you hold, FDA will still inspect you. That said, depending on the audit, it can serve as a credible certification of a food safety system in a plant and demonstrate to your customers your level of food safety commitment. And poor performance during an audit can find its way to FDA too, since in some instances the agency will have access to the conclusions of the audit and corrective actions taken in response to significant deficiencies identified during the audit. FDA initially proposed that serious issues uncovered during consultative audits conducted as part of the third-party accreditation of auditor program would be shared with FDA, and when audits are used as part of supplier programs, FDA will see how serious deficiencies in audits have been addressed. Be clear on why you are pursuing a particular audit, and take the program seriously. Audits should reflect your food safety culture, not serve as your motivation.

About The Author

Jennifer McEntire, Ph.D. is vice president of science operations at the Grocery Manufacturers Association. She was previously vice president and chief science officer at The Acheson Group, where she helped food industry clients understand their supply chain risks and prioritize mitigations in the context of the changing regulatory landscape and global food safety system. Prior to joining The Acheson Group, she served as the senior staff scientist and director of science & technology projects at the Institute of Food Technologists, and worked closely with FDA, FSIS, and CDC. McEntire earned her Doctor of Philosophy from Rutgers University and received a Bachelor of Science with Distinction,magna cum laude, in food science from the University of Delaware. She was the 2010 recipient of the Rutgers University Food Science Alumni Association Communication Award and in 2012 was honored with the University of Delaware College of Agriculture and Natural Resources Distinguished Young Alumni award. She can be reached at jmcentire@gmaonline.org.

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Scott Horsfall is Chief Executive Officer of the California Leafy Green Products Handler Marketing Agreement (LGMA). The LGMA verifies that California’s handlers of lettuce, spinach and other leafy green products are following a set of accepted food safety standards on the farm. The LGMA was formed in February of 2007, and Horsfall joined the organization in May of that year as its first CEO.
From 2002 through 2006 Horsfall was CEO of the Buy California Marketing Agreement, the organization designed to promote sales and consumption of locally-grown produce. Joining the “California Grown” campaign as Chief Operations Officer in 2002, Horsfall oversaw the creation of its marketing programs, and was promoted to CEO in 2003.

Prior to joining “California Grown”, Horsfall was President of the California Kiwifruit Commission (CKC), a position he held from 1997 to 2002. The CKC implements marketing and research programs on behalf of the state’s 400+ kiwifruit farmers.

Horsfall began his career in California agriculture with the California Table Grape Commission, Fresno, CA, where he served most recently as Vice President, International Marketing. At the CTGC, Horsfall oversaw an annual $3.5 million export promotion program. During his tenure grape exports increased over 600% in 14 years. He has served on several industry boards and committees. He served as chairman of the United States Agricultural Export Development Council (USAEDC), was a member of the Agricultural Trade Advisory Committee (ATAC) for fruits and vegetables and is a past chairman of the Produce Marketing Association’s International Trade Conference.

Horsfall has a MA in international relations from California State University/Fresno and a BA in communications from Brigham Young University in Provo, Utah.

Steven Sklare is the director of customer engagement – Foods Program for the United States Pharmacopeia. Sklare’s focus is on helping the food industry and the public understand the significance of food fraud as a threat to public health, a food organization’s brand as well as a source of economic fraud. His background includes working with food manufacturers, the foodservice/hospitality industry, and retail food as a provider of food fraud, food safety, sanitation and pest elimination consulting, training and services on a domestic and international basis. Sklare is a registered environmental health specialist, licensed environmental health practitioner, and certified professional – food safety and certified pest control technician.

Mike Robach is the vice president, of corporate food safety, quality & regulatory at Cargill, Inc. He joined the company in January 2004 to lead its corporate food safety and regulatory affairs programs. Since that time, he has increased the department’s scope to include animal health and quality assurance. He continues to refocus the department toward global efforts in line with Cargill’s vision of being the global leader in nourishing people.

Robach started out his career with Monsanto Company. Prior to joining Cargill, Robach headed up technical services for Conti Group’s meat and poultry businesses. He is a graduate of Michigan State University and Virginia Tech. He is past President for Safe Supply of Affordable Food Everywhere (SSAFE), Chairman of the Board of Directors of the Global Food Safety Initiative (GFSI), a member of the Scientific and Regulatory Affairs Council Executive Committee for the Grocery Manufacturers Association, and a member of the U.S. Poultry and Egg Association’s Research Advisory Committee. He is also a member of the American Meat Institute, the National Turkey Federation, the International Association of Food Protection, the Institute of Food Technologists, and the American Society for Microbiology. Robach has worked with the World Organization of Animal Health (OIE) and the Food and Agriculture Organization (FAO) on harmonized animal health andfood safety standards. He has worked closely with the USDA and FDA regarding food safety policy, HACCP, and regulatory reform based on science. From 1995 through 2000, Robach was a member of the National Advisory Committee for Microbiological Criteria in Foods.

An experienced veteran in food safety, Patricia Wester has held advanced positions in both domestic and international food safety firms. She is currently president of her own consulting company, PA Wester Consulting, which allows her to utilize her experience in food safety and auditor competence as an active subject matter expert on a wide range of development projects for preventive controls and food safety auditor personnel certification schemes and training. In 2017 Wester launched The Association for Food Safety Auditing Professionals, a member-driven association created to support and enhance the career development path for food safety auditors. She is also currently a technical auditor for ANSI in food safety. She received her bachelor of science in poultry science from the University of Florida, and has held senior management positions within the meat and poultry processing industry.

Palmer A. Orlandi, Jr., Ph.D., senior science officer and research director in FDA’s Office of Foods and Veterinary Medicine, was recently promoted to the rank of Rear Admiral and the U.S. Assistant Surgeon General. Orlandi joined FDA 20 years ago, beginning his work at a research lab for CFSAN. It was there that he developed rapid and molecular detection methods for Cyclospora and Cryptosporidia and the Microsporidia (emerging food-and waterborne protozoan parasites). In 2008 he became the science coordinator in the Division of Field Science in FDA’s Office of Regulatory Affairs (ORA) where he oversaw collaborative analytical methods programs for ORA and the Food Emergency Response Network. In 2012 Orlandi took on the role of senior science advisor to the chief scientist officer at the Office of Food and Veterinary Medicine. He played an active role in integrating science and research efforts across the agency’s foods program, and working to align research and lab programs to regulatory field lab needs.

Darin Detwiler, M.A.Ed., DLP is the director: regulatory affairs of food and food industry, assistant teaching professor in the College of Professional Studies at Northeastern University. Prior to this role, he was the senior policy coordinator for food safety at STOP Foodborne Illness, (a national non-profit public health organization dedicated to the prevention of illness and death from foodborne illness.). Detwiler has spent two decades working in the support and reform of food policy. Four different secretaries of agriculture have recognized Detwiler for his efforts in the USDA’s Pathogen Reduction Program. From 2004–2007, he served on the USDA’s National Advisory Committee on Meat and Poultry Inspection. He is also an FDA-certified food science educator whose work can be found on television, radio and in industry journals and newspapers, including the New York Times. Detwiler is a former high school teacher and adjunct professor of science and history, as well a navy veteran.

Melanie Neumann of Neumann Risk Services, LLC,

Melanie Neumann, J.D., M.S. is the president and global food safety attorney of Neumann Risk Services, LLC (NRS). NRS provides regulatory, business and brand counsel to help the food and beverage industry manage these various risks. NRS is a holistic food safety risk management firm where food law, food safety, food science and brand reputation converge. With more than 18 years of experience advising food and beverage companies, Neumann leverages her years as an attorney along with her master’s degree in food safety to help clients understand the risks relating to food laws and regulatory compliance from compliance, operational and brand perspectives. This involves working with companies to interact with regulators in response to investigation findings, enforcement actions and recalls, FSMA compliance and other FDA and USDA regulations. Neumann also works with companies to identify risk-based strategies to manage supply chain risks through an enterprise risk management approach and helps clients tackle emerging food safety risks and regulatory changes in both the United States and international markets.

Neumann is active in the Global Food Safety Initiative (GFSI), is a technical working group member of the GFSI Global Markets Program Strategy, as well as a member of the Scientific Organization Committee of The Sackler Institute of Nutrition Science of the New York Academy of Sciences. She is an avid runner, marathoner, triathlete and four-time Ironman finisher.

Gina Nicholson-Kramer, RS/REHS is the Executive Director of Savour Food Safety International, where she specializes in assisting companies in developing long-term food safety culture and behavior change programs, starting with the top to the front-line employee. She also specializes in internal and external food safety communication plans during times of crisis for food companies. She has developed a mentorship program for food safety professionals, coaching them how to build a program that is a profit center not a cost center for their company. Nicholson-Kramer works with companies on new products and technologies from ideation to commercialization. Formerly the global director of retail food services for NSF International, she oversaw NSF’s team of retail food safety experts for third-party auditing, consulting and technical services for major global retail brands such as Sodexo, HMS Host, T.G.I. Friday’s and Jack in the Box.

As an owner and operator of her own organic bakery, to Manager of Public Health Promotions and a Registered Sanitarian at the Columbus Public Health Department, to her role as Senior Manager of Food Safety & Quality at The Kroger Co., Gina Nicholson-Kramer has spread her knowledge and innovative approach of food safety to organizations small and large.

Nicholson-Kramer is an active member of several food safety committees, including The Ohio State University Environmental Health Sciences Advisory Board, STOP Foodborne Illness Chairperson of the Board of Directors, as well as several committees with the Conference for Food Protection, and the International Association for Food Protection (she is chair of the Retail Foodservice PDG). She attended Ohio-based Ashland University where she obtained her Bachelor’s degree in Human Biology. She is also a Registered Sanitarian in the state of Ohio and a Registered Environmental Health Specialist through the National Environmental Health Association.

Jorge Hernandez is the chief food safety officer at Wholesome International where he is responsible for the design and implementation of the food safety, quality assurance, regulatory compliance and sustainability programs. Wholesome International is a restaurant company with different concepts and brands in the quick service and fast casual foodservice markets. Hernandez was previously the senior vice president of food safety and quality assurance at US FOODS, vice president of food safety and risk management at the National Restaurant Association and regional supervisor at the Illinois Department of Public Health. Hernandez received a B.S. degree in biology from Rockford University, a degree in microbiology from the Centro de Estudios Medico-Biologicos in Mexico City, Mexico and a degree in languages and literature from Universite de la Sorbonne, Paris, France. He belongs to several national and international organizations and boards, including the Global Food Safety Initiative (GFSI), STOP Foodborne Illness, Food Safety Tech and the Food Safety Consortium, the International Food Protection Institute (IFPTI), Food Safety Summit, QA Magazine and the ANSI Accreditation Committee.

John Butts received his Ph.D. in Food Science from Purdue University in 1974 & joined Land O’ Frost 1974. He is a member of the Board of Directors of the American Meat Institute and is an active member of the Scientific Affairs Committee (SAC) for over 35 years. He serves on the Meat Inspection Committee, Facility Design Task Force, AMIF Research Advisory and is an AMI Listeria Intervention and Control Workshop team member, co-author and instructor. Butts received the 2005 Food Safety Leadership Award, NSF International. Outstanding Food Science Award, Inaugural class recipient, Purdue University, 2006 Food Safety Magazine Distinguished Service 2008 Meat Processing Award by the AMSA. 2009 AMIF Scientific Achievement Award and the 2013 Certificate of Distinction from Purdue Ag Alumni.

Shawn K. Stevens is a food safety lawyer and founding member of Food Industry Counsel, LLC, the only law firm in the world that represents the food industry exclusively. Stevens works throughout the country and abroad with food industry clients (including the world’s largest food processors, national restaurant chains, and food distributors and grocers), helping them protect their brand by proactively eliminating their food safety risk, complying with complex FDA and USDA food safety regulations, managing recall response efforts, and defending high-profile foodborne illness claims. Stevens speaks regularly to national and international audiences on a wide variety of emerging scientific, regulatory and legal food safety trends, authors dedicated columns for Meatingplace and The National Provisoner, and is quoted regularly by national media publications such as TIME Magazine, the New York Post, and Corporate Counsel Magazine.

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